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Canadian MDR Documentation
Canadian Medical Device Regulations
Selling medical devices in Canada?
Need to establish compliance with regulatory requirements?
Need to improve effectiveness of your QMS?
Folks on the floor do not always follow procedures?
Wish you could do things right the first time?
We can help!
If your company sells medical devices
in Canada, the company is required to maintain a quality
management system compliant with the Canadian Medical Device Regulations
(MDR). This system is based on ISO 13485 standard and includes
additional specific to Canada requirements. Quality Works team has developed
and offers documentation templates for ISO 13485 Quality Management
System (QMS). Use of templates is a widely used approach to
establishing and documenting a quality management
system. Quality Works assisted dozens of companies around the World in
establishing and implementing effective QMS. Our documentation will save
you time and money in documenting your Canadian MDR compliant quality
Feel free to compare our documentation with others: you will find that
our products are the most effective, simple and yet addressing all the
requirements of Canadian MDR regulation. Quality
Works team designed our documentation to establish compliance with the
requirements and improve effectiveness of
your documentation system to reduce paperwork. Our documentation
is user-friendly, easy to understand and makes good business sense.
Check our Download page to see
samples of our documents. While our ISO 13485 and Canadian MDR quality
management system documents are easy to customize and implement, our
team is always here to assist you in your project. Check our
Consulting, Training and Auditing pages to learn
how our experts can give you a jump-start in developing and implementing
your Canadian MDR quality management system. Visit our
Product page to order your
medical device QMS documents.
Call us today to discuss
your specific ISO management system needs!